Dexafort Suspension for injection 50ml

Dexafort Suspension for injection 50ML.

Presentation

An aqueous, white suspension for injection. Each ml contains:

Dexamethasone sodium phosphate 1.38 mg

Dexamethasone phenylpropionate 2.67 mg

Preservative:

Benzyl alcohol 10.4 mg

Uses

Dexafort is indicated for use as an anti-inflammatory and anti-allergic agent in horses, cattle, dogs and cats, and for the treatment of primary ketosis in cattle. The product can also be used to induce parturition in cattle.

Dosage and administration

Shake vial before use.

Dexafort should be administered by intramuscular injection using normal aseptic techniques. To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate administration of the correct dose. Avoid accidental self-injection with this product.

For the treatment of inflammatory or allergic conditions

The following average doses are advised. However, the advised dose used should be determined by the severity of the signs and the length of time for which they have been present.

Species

Dosage

Horses, cattle

1  ml/50 kg

Dogs, cats

0.5 ml/10 kg

For the treatment of primary ketosis in cattle (acetonaemia)

A dose of 5-10 ml dependent on the size of the cow. Since blood sugar levels rise rapidly through the action of dexamethasone sodium phosphate and are maintained at a raised level for several days, the product is particularly useful in cases that present late and there is seldom a need to repeat the dose.

In the case of cows in poor bodily condition, to avoid prolonged stimulation of gluconeogenesis at the expense of body fat reserves, use a quick-acting corticosteroid only.

For the induction of parturition

Dexafort may be used to induce parturition in cattle in the last trimester and before day 260 of pregnancy. Where this is required e.g. in the cases of trauma to the cow or possibly because the date of calving is not known a single dose of 10 ml followed 6–12 days later by an injection of a short acting corticosteroid, is recommended. In the majority of cases parturition will be induced within 3 days of the second injection.

Contra-indications, warnings, etc

Contra-indications

Except in emergency situations the product should not be used in animals suffering from diabetes, chronic nephritis, renal disease, congestive heart failure, osteoporosis and in viral infections during the viraemic stage.

General warnings

1. Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control clinical signs.

2. Steroids themselves, during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result.

3. During therapy effective doses suppress the hypothalamo-pituitreal-adrenal axis. Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. dosing to coincide with the time of the endogenous cortisol peak (i.e. in the morning with regard to dogs and the evening re cats) and a gradual reduction of dosage (for further discussion see standard texts).

4. Systematically administered corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use. Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis).

5. Apart from the use of Dexafort to induce parturition in cattle, corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion.

6. If the product is used for induction of parturition in cattle a high incidence of retained placentae may be experienced and possible subsequent metritis and/or subfertility.

7. Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, antibacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.

8. Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. Gastro-intestinal ulceration has been reported in animals treated with corticosteroids and g.i.t. ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

9. Care should be taken when the product is used for the treatment of laminitis in horses, where there is the possibility that such treatment could worsen the condition. The use of the product in horses for other conditions could induce laminitis and careful observations during the treatment period should be made.

10. Use of the product in lactating cows may cause a reduction in milk yield.

11. During a course of treatment the situation should be reviewed frequently by close veterinary supervision.

Operator warnings

Care should be taken to avoid self-injection. If accidental self–injection occurs, seek medical attention and show the label to the doctor. Avoid contact with skin and eyes. In the event of accidental eye or skin contact, wash/irrigate the area with clean running water. Seek medical attention if irritation persists. Wash hands after use.

Withdrawal periods

Cattle: Meat – 63 days

Milk – 144 hours

Not for use in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Shake vial before use.

Following withdrawal of the first dose, use the product within 28 days. When the vial is broached for the first time, use the in-use shelf life which is specified on the packaging to calculate the date on which any remaining product should be discarded. This discard date should be written in the space provided on the label. Discard unused material.

Keep container in outer carton. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

50 ml vials.